Self Etching Primer SEPR

GUDID D798SEPR0

The Reliance S.E.P.™ is a self etching primer refill cartridge intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.

RELIANCE ORTHODONTIC PRODUCTS INC

Dental etching solution
Primary Device IDD798SEPR0
NIH Device Record Key6d49348a-fd44-4d94-b49f-b05c4a9f01cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelf Etching Primer
Version Model NumberSEPR
Catalog NumberSEPR
Company DUNS113170088
Company NameRELIANCE ORTHODONTIC PRODUCTS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone630-773-4009
Emailpaulgropi@aol.com
Phone630-773-4009
Emailpaulgropi@aol.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
Special Storage Condition, SpecifyBetween 0 and 0 *TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD798SEPR0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-13

On-Brand Devices [Self Etching Primer]

D798SEPR0The Reliance S.E.P.™ is a self etching primer refill cartridge intended to be used for the pre
D798SEPPRO0The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of
D798SEPD0The Reliance S.E.P.™ is a self etching primer dispenser is intended to be used for the deliver
D798SEPC0The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of

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